Eluna Family / Sentus BP Master Study

Completed

• Conditions: Heart Failure; Bradycardia
• Interventions: Device: Eluna pacemaker family; Device: Sentus BP lead

• Registration Number: NCT02059629
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead.

Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-11
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

• Patient is willing to participate in the study and provided written informed consent
• Patient meets standard indication for pacemaker or CRT-P or CRT-D therapy
• Patient accepts Home Monitoring® concept
• Patient has legal capacity and ability to consent

Exclusion Criteria

• Patient with any contraindication to pacemaker and CRT-P and CRT-D therapy
• Patient under the age of 18
• Pregnant or breast-feeding women
• Cardiac surgery planned within the next 6 months
• Life expectancy less than 12 months
• Participation in another cardiac clinical investigation with active treatment arm
• Group B only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead (for CRT implants only)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: Eluna pacemaker family	Eluna pacemaker family	Patients with standard indication for pacemaker therapy or Cardiac Resynchronization Therapy (CRT), who will be implanted with a pacemaker or CRT device of the Eluna pacemaker family. Single-, Dual- and Tripple-chamber pacemakers are applicable.
Group B: Sentus BP lead	Sentus BP lead	Heart failure patients with indication for Cardiac Resynchronization Therapy (CRT) therapy, who will be implanted with the left ventricular Sentus BP lead. Patients can receive either CRT pacemaker or CRT-D (CRT with defibrillator function).

Primary Outcome Measures

Name	Time	Method
Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate	6 months	The safety of the Eluna pacemaker family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.
Sentus BP lead: Serious Adverse Device Effect (SADE) - free rate	3 months	The safety of the Sentus BP left ventricular lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the Sentus BP lead will be the basis for endpoint calculation of the SADE free rate.

Trial Locations

Locations (17)

Aalborg Sygehus; 🇩🇰 Aalborg, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Klinikum Lippe; 🇩🇪 Detmold, Germany

Universitätsklinikum Erlangen, Medizinische Klinik 2; 🇩🇪 Erlangen, Germany

Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen; 🇩🇪 Essen, Germany

Universitäts-Herzzentrum Freiburg; 🇩🇪 Freiburg, Germany

Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis; 🇩🇪 Saarlouis, Germany

Universitätsmedizin Greifswald; 🇩🇪 Greifswald, Germany

Allgemeines Krankenhaus Linz; 🇦🇹 Linz, Austria

Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Cliniques du Sud Luxembourg; 🇧🇪 Arlon, Belgium

ZOL Genk; 🇧🇪 Genk, Belgium

Elisabeth Krankenhaus Essen; 🇩🇪 Essen, Germany

St. Marien-Hospital Lünen; 🇩🇪 Lünen, Germany

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong